Cation Adjusted Mueller Hinton Broth

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K925644 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Pasco Laboratories, Inc. →

• What is the primary use of the Cation Adjusted Mueller Hinton Broth in a clinical microbiology lab?

  The Cation Adjusted Mueller Hinton Broth is specifically designed for quantitative antimicrobial susceptibility testing, particularly for determining the Minimum Inhibitory Concentration (MIC) of antibiotics. It is the recommended medium for testing rapidly growing aerobic and facultatively anaerobic bacteria derived from clinical specimens, ensuring accurate results for guiding treatment decisions.

• How is the Cation Adjusted Mueller Hinton Broth supplied, and is it intended for single-use or reuse?

  The product is supplied as a broth medium for laboratory use in susceptibility testing. The provided data does not specify whether it is sterile, single-use, or reusable, so its handling and reuse would depend on the laboratory’s standard operating procedures and infection control protocols.

• What regulatory pathway was followed for FDA clearance of this product, and under which category is it classified?

  The Cation Adjusted Mueller Hinton Broth was cleared through a traditional 510(k) pathway (K925644) and is classified as a Class II medical device under 21 CFR 866.1640. It was reviewed by the Microbiology (MI) Advisory Committee and determined to be substantially equivalent to a predicate device.

• What are the key product codes and regulatory details associated with this device?

  This device is regulated under product code JWY and falls under the broader category of Manual Antimicrobial Susceptibility Test Systems, as defined by the FDA. It is listed under 21 CFR 866.1640 and has multiple registration numbers (e.g., 3003750284) associated with its compliance and reporting requirements.